Single vs Multi-Dose Insulin for Glycemic Control (SUGAR)

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT07171684
Status
Recruiting
Apply to this trial

Conditions

  • Diabetes in Pregnancy
  • Gestational Diabetes

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Insulin glargine alone — DRUG
    Once daily dosing of insulin glargine
  • Insulin glargine + insulin lispro — DRUG
    Once daily dosing of insulin glargine + three times daily dosing of insulin lispro with meals

Study Details

The goal of this clinical trial is to see if diabetes in pregnancy can be treated with once daily dosing of insulin instead of once daily dosing plus insulin with meals. The main question this study aims to answer is: 1. Can a once daily dose of long-acting insulin control blood sugars as well as long-acting insulin plus meal-time insulin? 2. Do babies born to mothers who take one dose of long-acting insulin have more complications after birth than babies born to mothers who take long-acting and meal-time insulin? Researchers will compare one dose of long-acting insulin per day to this plus three doses of short-acting insulin with each meal to see if blood sugars are controlled. Participants will send their blood sugar logs to the study staff weekly, instead of to their OB/GYN, for adjustments to their insulin dosing.

Key Dates

Start date
Nov 26, 2025
Status verified
Apr 2026
Primary completion
Oct 1, 2026
Completion
May 15, 2027

Study Design

Enrollment
176 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Insulin glargine alone
    Once daily dosing of insulin glargine
  • Active Comparator: Insulin glargine + Insulin lispro
    Once daily dosing of insulin glargine plus three times per day dosing of insulin lispro with each meal

Primary Outcome Measure

Composite outcome [ Time Frame: From enrollment to delivery ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Robert Wood Johnson Univeristy HospitalNew BrunswickNew Jersey08901
Emily Rosenfeld, DO
[email protected]
7322356632
Maternal-Fetal Medicine at NYU Langone Obstetrics & Gynecology AssociatesNew YorkNew York10022
Lucia Muzzarelli
[email protected]
(646) 754-2700

Find similar trials in New Brunswick, NJ

By research site
Robert Wood Johnson Univeristy Hospital· New Brunswick, NJMaternal-Fetal Medicine at NYU Langone Obstetrics & Gynecology Associates· New York, NY

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